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Dietary Supplement

GlaucoCetin for Glaucoma

Q: Does the study include elderly candidates?

<p>The parameters for patient participation in this medical experiment stipulate that the youngest age eligible to enroll is 40, while the oldest participant must not exceed 80 years old.</p>

Q: What is the scope of this clinical trial's participant base?

<p>Affirmative. The official information from clinicaltrials.gov states that the study is actively recruiting individuals, and was first posted on February 1st 2021 with a most recent update recorded by June 30th 2022. This trial necessitates recruitment of 100 patients to just one site.</p>

N/A

Recruiting

Led By Natasha N Kolomeyer, MD

Research Sponsored by Wills Eye

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minute questionnaires during a 6 month period

Awards & highlights

Study Summary

This trial is testing whether a daily medical food can improve the vision of glaucoma patients.

Who is the study for?

This trial is for people aged 40-80 with open-angle glaucoma, controlled eye pressure, and good visual acuity. Participants must have specific types of visual field defects but no other significant eye diseases or recent surgeries. They shouldn't be on certain medications like nitroglycerin or anti-seizure drugs, nor should they have uncontrolled blood pressure or diabetes.Check my eligibility

What is being tested?

The study tests GlaucoCetin, a medical food designed to protect optic nerve cells in glaucoma patients against a placebo over six months. Patients are randomly chosen to receive either the treatment or placebo to see if there's an improvement in vision.See study design

What are the potential side effects?

Potential side effects aren't detailed here but could relate to ingredients in GlaucoCetin such as Curcumin and Ginkgo Biloba which may cause digestive upset or allergic reactions in some individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 minute questionnaires during a 6 month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 minute questionnaires during a 6 month period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minute questionnaires during a 6 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Field Mean Deviation

Secondary outcome measures

Perceived Quality of Life Improvement

Perceived Quality of Life Improvement measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: GlaucoCetin Peripheral GroupActive Control1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group II: GlaucoCetin Central GroupActive Control1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group III: Placebo Peripheral GroupPlacebo Group1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Group IV: Placebo Central GroupPlacebo Group1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Guardian Health Sciences, Inc.UNKNOWN

Wills EyeLead Sponsor

79 Previous Clinical Trials

10,336 Total Patients Enrolled

48 Trials studying Glaucoma

4,896 Patients Enrolled for Glaucoma

Natasha N Kolomeyer, MDPrincipal InvestigatorWills Eye Hospital

Media Library

GlaucoCetin (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04784234 — N/A

Glaucoma Research Study Groups: GlaucoCetin Peripheral Group, Placebo Peripheral Group, GlaucoCetin Central Group, Placebo Central Group

Glaucoma Clinical Trial 2023: GlaucoCetin Highlights & Side Effects. Trial Name: NCT04784234 — N/A

GlaucoCetin (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784234 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this testing opportunity still accepting participants?

"Affirmative. According to the records available on clinicaltrials.gov, recruitment for this medical investigation is still happening. It was first announced February 1st 2021 and most recently updated June 30th 2022 with the aim of enrolling a hundred patients across one site."

Answered by AI

How can I become involved in this clinical experiment?

"This medical trial requires 100 individuals between the ages of 40 and 80 who have been diagnosed with open-angle glaucoma. Additionally, Group 1 must meet at least one Hodapp-Parrish-Anderson criterion for defect; Group 2 must demonstrate a paracentral point repeatedly depressed to p<1% on 24-2 testing. Moreover, both groups should possess bilateral open angle glaucoma that can be corroborated by visual field defects (MD between -4.00 to -10 dB). Lastly, all participants need to present with an acuity level of 20/40 or better in each eye."

Answered by AI

Does the study include elderly candidates?

"The parameters for patient participation in this medical experiment stipulate that the youngest age eligible to enroll is 40, while the oldest participant must not exceed 80 years old."

Answered by AI

What is the scope of this clinical trial's participant base?

"Affirmative. The official information from clinicaltrials.gov states that the study is actively recruiting individuals, and was first posted on February 1st 2021 with a most recent update recorded by June 30th 2022. This trial necessitates recruitment of 100 patients to just one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Natasha Nayak Kolomeyer, MD 2021. "Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04784234.

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